A Study Looking to Improve Sleep and Reduce Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus

Launched by UNIVERSITY OF LEICESTER · Jun 17, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to help people with Type 2 diabetes who are having trouble sleeping and tend to be less active during the day. The researchers want to find out if they can improve sleep quality and encourage more movement in these individuals. Participants will be asked to keep a sleep diary and meet regularly with a coach who will guide them through conversations and techniques designed to improve their sleep and reduce the time they spend sitting. The trial will compare the results of those who receive this support with a control group to see if there are any significant differences.

To be eligible for this study, participants should be between 18 and 75 years old, have been diagnosed with Type 2 diabetes for at least three months, and have some symptoms of insomnia. They should also be able to walk independently and not be engaging in excessive exercise. It's important to note that individuals with certain medical conditions, such as severe sleep disorders or recent heart issues, won’t be able to participate. If someone joins the study, they should be prepared for some initial challenges with their sleep, as the treatment may temporarily make sleep difficulties worse. Overall, this trial aims to provide valuable insights into improving both sleep and daily activity levels for those living with Type 2 diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosed with Diabetes Mellitus type 2 for longer than 3 months
• • Participant is willing and able to give informed consent to take part in the study.
• • Sleep disorder symptom checklist 25 (SDS-CL-25) of ≥5 on insomnia criteria.
• • Not at high risk of undiagnosed Obstructive Sleep Apnoea (OSA), scoring ≥5 on STOP BANG scale (snoring, tired, observed, pressure, body mass index, age, neck size, gender) diagnosed treated OSA is acceptable.
• • Glycated haemoglobin (HbA1c) of 10% or less (86 mmol/mol) or less
• • Male or Females.
• • ≥ 18 ≤ 75 years of age.
• • Able to walk without the use of an assistive device or requiring assistance from another person.
• • Not undertaking more than 75 minutes a week of strenuous exercise or sport.
• • Not taking opioids
• • Be treatment stable for at least 3 months
• • Accelerometer measurement of SE ≤ 85%
• • An understanding that CBTi may exacerbate sleep deprivation in the short term which may impact on certain aspects of daily life.
• Exclusion Criteria:
• • Individuals living with narcolepsy or diagnosed parasomnia
• • Individuals with type 1 diabetes or gestational diabetes
• • Recent cardiovascular event (within the last 6 months).
• • Currently on opioids
• • Diagnosed with borderline personality disorder, psychosis, adult attention deficit hyperactivity disorder (ADHD) or schizophrenia (self-reported).
• • Individuals living with epilepsy or seizures.
• • Shift workers
• • Female participant planning to become pregnant with the timeframe of the study or is currently pregnant.
• • Terminal illness.